UroGen Pharma Ltd. says its phase 3 ENVISION study of investigational agent UGN-102 (mitomycin) for intravesical solution in development for the treatment of LG-IR-NMIBC is fully enrolled.
The study targeted enrollment of 220 patients across 90 sites and, assuming positive findings, UroGen anticipates submitting a New Drug Application (NDA) for UGN-102 in 2024.
“Completing enrollment for the ENVISION trial is a major milestone that brings us one step closer to validating chemoablation for the treatment of LG-IR-NMIBC,” said Sandip Prasad, director of Genitourinary Surgical Oncology, Morristown Medical Center, Atlantic Health System, NJ, and lead study investigator for the ENVISION trial.
“These patients are burdened with disease recurrences and repeat surgeries that take a toll on an elderly population who often have co-morbidities that increase the risks associated with surgery. If successful ENVISION has the potential to fundamentally change the way we treat these patients.”
UroGen Pharma‘s study details
ENVISION is a phase 3, single-arm, multinational, multicenter study evaluating the efficacy and safety of UGN-102 as primary chemoablative therapy, in 220 patients with LG-IR-NMIBC from 90 sites. The design for the trial is similar to the phase 2b OPTIMA II trial in that the patient population will have similar clinical characteristics, receive the same treatment regimen and undergo the same efficacy and safety assessments and qualitative follow-up.
Patients enrolled in ENVISION will receive six once-weekly intravesical instillations of UGN-102. The primary endpoint is the complete response rate at PDE (primary disease evaluation), which will typically occur within three months from the first instillation, and the key secondary endpoint will be durability of response in patients who achieve complete response.
“We are optimistic about the clinical potential of UGN-102 because ENVISION shares a similar approach to the successful OPTIMA II phase 2b study,” said Mark Schoenberg, chief medical officer, UroGen.
“Also, our chemoablative treatment for low-grade upper tract urothelial cancer and UGN-102 uses our proprietary RTGel technology, and the urothelial lining in the bladder and upper tract is similar. If approved, UGN-102 may offer additional advantages because it is instilled into the bladder via urethral catheter in an outpatient setting – a common procedure in most urologists’ offices.”
If approved, UGN-102 has the potential to offer a simpler, minimally invasive, and non-surgical option to transurethral resection of bladder tumor (TURBT), as UGN-102 can be administered without the use of anesthesia or special equipment. UroGen’s first product and UGN-102 utilize mitomycin as their active pharmaceutical ingredient, although in a different ratio and both allow for local delivery and sustained exposure to mitomycin for up to six hours.